Electronic Intervention for HIV Medication Adherence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kasey Claborn, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT01291485
First received: January 10, 2011
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to develop and examine the feasibility and initial efficacy of a computer-based intervention to improve medication adherence among people living with HIV.


Condition Intervention
HIV
Behavioral: Life Steps for Medication Adherence

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Randomized Clinical Trial Examining the Efficacy of an Electronic Intervention for HIV Medication Adherence

Resource links provided by NLM:


Further study details as provided by Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • HIV medication adherence [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Self-reported adherence to HIV medications will be assessed using the AACTG Medication Adherence Questionnaire (M. A. Chesney, et al., 2000).


Secondary Outcome Measures:
  • HIV Treatment Adherence Self-Efficacy [ Time Frame: Baseline, 1-month, 3 months, and 6-months ] [ Designated as safety issue: No ]
    Self-efficacy for adherence to HIV medications will be assessed using the HIV-ASES (Johnson et al., 2007). The HIV-ASES is a 12-item scale of patient confidence in their ability to carry out behaviors related to adhering to medication regimens. Responses range from 1 ("cannot do it at all") to 10 ("completely certain can do it"). Item scores are averaged with higher scores indicating higher adherence self-efficacy.

  • Quality of Life [ Time Frame: Baseline, 1-month, 3-months, and 6-months ] [ Designated as safety issue: No ]
    Quality of life will be assessed using the McGill Quality of Life questionnaire (S. Robin Cohen, Hassan, Lapointe, & Mount, 1996). This instrument is a 16-item scale that assesses quality of life in four domains: physical well-being, psychological well-being, existential well-being, and support; each item is assessed on a 0-10 point scale.

  • Viral Load [ Time Frame: Baseline, 1 month, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Baseline, 1 month, 3 months, and 6 months ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
Intervention includes education about HIV and medication adherence, motivational interviewing, cognitive behavioral techniques, and problem-solving strategies to improve HIV medication adherence and clinical outcomes.
Behavioral: Life Steps for Medication Adherence
The intervention was adapted into an electronic version of the empirically supported Life Steps intervention for HIV medication adherence. Education about HIV and medication adherence, motivational interviewing, cognitive behavioral techniques, and problem-solving strategies to improve medication adherence and clinical outcomes in people living with HIV were also included in the intervention.
No Intervention: Treatment as Usual

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infected with HIV
  • over age 18
  • currently prescribed a Highly Active Antiretroviral Therapy (HAART) regimen
  • prescribed a regimen for the first time, changing regimens, or report adherence below 95% agree to brief follow-up interviews

Exclusion Criteria:

  • physical impairment that would prevent them from successfully completing the computer-based program (e.g., blind, deaf, severe neuropsychological impairment)
  • Actively psychotic
  • Not fluent in English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291485

Locations
United States, Oklahoma
Internal Medicine Specialty Services
Tulsa, Oklahoma, United States, 74127
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Study Director: Thad R Leffingwell, Ph.D. Oklahoma State University
Principal Investigator: Kasey R Claborn, M.S. Oklahoma State University
Study Chair: Johnny Stephens, Pharm.D. Oklahoma State University Center for Health Sciences
  More Information

No publications provided

Responsible Party: Kasey Claborn, Doctoral Candidate, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT01291485     History of Changes
Other Study ID Numbers: 2010022
Study First Received: January 10, 2011
Last Updated: October 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:
HIV
Medication adherence
computer-based intervention

ClinicalTrials.gov processed this record on September 16, 2014